Status:
COMPLETED
Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes
Lead Sponsor:
Tor Biering-Sørensen
Collaborating Sponsors:
Sanofi
Hospital Clinico Universitario de Santiago
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
This prespecified analysis will pool the datasets from two pragmatic randomized trials evaluating the relative vaccine effectiveness of high-dose vs. standard-dose influenza vaccine against severe cli...
Eligibility Criteria
Inclusion
- Pragmatic trials conducted to estimate the relative vaccine effectiveness of high-dose influenza vaccine compared with standard-dose influenza vaccine using the DANFLU-2 protocol or a protocol developed based on the DANFLU-2 protocol
Exclusion
- Low data quality
- Influenza circulation threshold was not met in any of the study seasons
- Severe under-enrollment in all seasons
Key Trial Info
Start Date :
May 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
466320 Patients enrolled
Trial Details
Trial ID
NCT06506812
Start Date
May 31 2025
End Date
August 31 2025
Last Update
September 12 2025
Active Locations (1)
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1
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Capital Region, Denmark, 2900